HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY).— 510(k) K991444
Substantially EquivalentComputer Motion, Inc.
FDA 510(k) clearance K991444 for HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY)., Substantially Equivalent on 1999-06-25. Applicant: Computer Motion, Inc..
Clearance details
- Applicant
- Computer Motion, Inc.
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.